MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN POLY; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_WWA

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 02/20/2023

Event Type  Injury  

Manufacturer Narrative

The device is not available for evaluation as it remains implanted in the patient.A review of the device history is not possible because the lot number was not communicated.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision surgery because the poly has worn down.

Event Description

It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision surgery because the poly has worn down.

Manufacturer Narrative

The reported event could not be confirmed since the poly was not returned and no assessment could be made on the ct imaging provided.Upon further investigation of the ct scans by healthcare professionals the following was observed, "there is clear radiolucence around the distal tibial component, and there are cavities around the implant.As the surgeon assumes, that the tibial component is in place and intact and the tip of the implant does not show signs of loosening, i assume, that these findings were already present at the time of the insertion of the implant.Therefore i would assess these as not being loosened.And there is no clear sign of migration.The pe is not visible directly in the ct scan, however, the surgeon assumes that there might be some damage (wear) within the pe.Possible, but cannot be confirmed with the imaging only.The talar component is positioned in direct contact to large cavities, which are likely to impair the foundation of the implant.This can be assessed as loosening and the widened distance between the tibia and the talus could be used as a proof for the migration of the component.The talar component is loosened and has migrated." based on investigation, the root cause was attributed to a patient factors related issue.Regarding the allegation of a worn poly, no conclusion can be drawn based on the information provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling was not possible because the catalog number and lot number were not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: UNKNOWN POLY
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16565277
• MDR Text Key: 311499471
• Report Number: 3010667733-2023-00124
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WWA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 06/09/2023
• Supplement Dates FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male